Especialista Senior en Cumplimiento

The Senior Engineer (2nd Shift) in our Company's Research Labs (Pharm Ops Engineering) provides engineering and compliance support for the FLEx (Formulation, Laboratory & Experimentation) Center in Rahway, NJ. This role supports non‑sterile process equipment and utilities used in the manufacture of oral solid dosage (OSD) products across clinical, developmental, and commercial programs. The position operates with minimal supervision and serves as a key technical and compliance resource during second‑shift operations. Education Bachelor’s degree in engineering with a minimum of 5 years of experience supporting pharmaceutical manufacturing operations for oral solid dosage (OSD) formats Required Experience and Skills Demonstrated commissioning and qualification experience supporting GMP manufacturing equipment in regulated environments Hands‑on familiarity with OSD process equipment and operations, including granulation, milling, blending, drying, tablet compression and coating, and encapsulation Strong technical troubleshooting capability across mechanical, electrical, and automation systems Working knowledge of Quality systems, cGMP requirements, Good Documentation Practices (GDocP), and applicable Safety and Environmental policies and procedures Experience performing root cause analysis and supporting technical investigations in a manufacturing environment Familiarity with CMMS/CCMS platforms and validation documentation tools (e.g., Kneat) Strong organizational, time‑management, and communication skills with the ability to manage multiple priorities independently while collaborating effectively across cross‑functional teams Proficient with standard business and documentation software tools Key Responsibilities Independently provide second‑shift engineering support for OSD process equipment and associated utilities within a GMP manufacturing environment, operating with minimal supervision Develop and provide shift‑change notes to ensure seamless support to the 1st shift team. Act as the secondary technical escalation point by reviewing procedures, wiring diagrams, equipment drawings, vendor manuals, and calibration/maintenance records to diagnose and resolve issues. Support troubleshooting of equipment and process issues, and implement effective corrective actions in collaboration with Operations, Process Engineering, Quality, and site technical teams Apply engineering principles and OSD process knowledge to support routine manufacturing activities, deviation response, and investigation efforts Provide Quality Engineering support to ensure facilities, utilities, and equipment remain compliant, qualified, and fit for GMP clinical, developmental, and commercial operations Adhere to all applicable safety requirements Author, review, and maintain GMP documentation, including procedures, IQ/OQ protocols, qualification reports, and engineering drawings, in accordance with site and regulatory requirements Execute commissioning, qualification, and decommissioning activities in alignment with approved protocols, change controls, and site standards Required Skills Adaptability Analytical Testing Data Analysis Detail‑Oriented Deviation Management Equipment Qualification Equipment Troubleshooting GMP Compliance Good Manufacturing Practices (GMP) Manufacturing Operations Pharmaceutical Manufacturing Pharmaceutical Systems Procedure Reviews Process Architecture Process Design Process Engineering Process Hazard Analysis (PHA) Process Optimization Process Technologies Protocol Review Quality Engineering Root Cause Analysis (RCA) Software Documentation Strategic Thinking Inclusive Hiring & EEO Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement, and Learn more about your rights, including under California, Colorado and other US State Acts. Compensation The salary range for this role is $117,000.00 - $184,200.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. Benefits We offer a comprehensive package of benefits. Available benefits include medical, dental, vision, healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at #J-18808-Ljbffr Merck